Vascular mild cognitive impairment
Conditions
Interventions
Tianma Xingnao capsule:Gastrodia Xingnao capsule, orally, 3 capsules at a time, 3 times a day
Gastrodia Xingnao capsule simulator, orally, 1 capsule at a time, 3 times a day.
Fufangcongrongyizhi capsule:Compound Cistanche Yizhi capsule, orally, 4 capsules at a time, 3 times a day.
Sponsors
Yunnan Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western diagnostic criteria for vascular mild cognitive impairment: 1) Mild decline in cognitive function confirmed by patients or informed persons or doctors; 2) Mild impairment of overall cognitive function, MMSE score 27-29 points (total 30 points), using MMSE education adjustment values: university 27-29 points, middle school 25-29 points, primary school 24-29 points, illiterate 23-29 points; 3) Objective evidence of impairment of =1 cognitive domain; Executive function: TMT-A =70s (total 150s); Memory function: HVLT=18.5 points (total score 36 points); Visual space function: CDT=3 points (total score 4 points); Language function: BNT-2=22 points (total score: 30 points); 4) During screening, the head MRI plain scan within 3 months meets any of the following criteria: ?= 1 large vascular cerebral infarction; ?= 1 extensive or critical cerebral infarction; ? Multiple lacunar infarcts outside the brainstem (>2) or lacunar infarcts at 1-2 critical sites or lacunar infarcts at 1-2 non-critical sites with extensive white matter hypersignaling; ? Extensive or fused white matter high signal; ? Cerebral hemorrhage at key sites, or =2 cerebral hemorrhage; ? A combination of the above forms. ? Cognitive impairment is associated with cerebrovascular disease, with one of the following: I. sudden onset, the time of cognitive impairment is associated with =1 cerebrovascular disease event, cognitive impairment occurs within 3 months after stroke, and lasts for at least 3 months, and with the occurrence of multiple similar cerebrovascular disease events, it is manifested as a step progression or volatility; II. progressive onset, slow progression, evidence of significant impairment of information processing speed, complex attention, and/or frontal executive function, and one of the following characteristics: a. Early gait abnormalities, including a sense of walking imbalance, or repeated falls; b. Early onset of frequent urination, urgency to urinate, or other symptoms that cannot be explained by a urinary system disease; c. Personality or mood changes, such as loss of willpower, depression, or anxiety. (2) Those who meet the TCM diagnostic criteria of kidney deficiency and phlegm turbidness syndrome; (3) Patients aged 40-80 years old, regardless of gender; (4) The patient should have a certain level of literacy, be able to read simple newspapers and write simple sentences, and be able to communicate and understand instructions related to cognitive tests; (5) The patient has a stable caregiver; (6) Patients and their legal guardians voluntarily participate in clinical trials and sign informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be included: (1) Mild cognitive impairment caused by other causes (such as Alzheimer's disease, Parkinson's disease, lewy body disease, frontotemporal degeneration, Huntington's disease, epilepsy, encephalitis, subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease, vitamin deficiency, syphilis and severe anemia); (2) Primary psychosis (such as schizophrenia), depressive state (HAMD/17 =17 points) and anxiety state (HAMA=12 points) that meet DSM-V criteria; (3) Patients with certain diseases that can interfere with cognitive function evaluation, have serious neurological deficits that can not complete relevant examinations, such as convenient hand hemiplegia, various aphasia, audio-visual impairment, etc.; (4) Poor control of cardiovascular diseases, such as severe arrhythmia, patients with myocardial infarction within 3 months before participating in the trial, or patients with cardiac function grade ?-?, systolic blood pressure =90mmHg or =180mmHg; (5) Severe liver and kidney dysfunction, ALT or AST more than 2 times the upper limit of normal, or serum creatinine more than 1.5 times the upper limit of normal; (6) With uncontrolled diabetes mellitus, the HBA1c value exceeds 10% or more; (7) Complicated with acute attack of asthma, acute exacerbation of chronic obstructive pulmonary disease, multiple neuritis, myasthenia gravis and muscular atrophy; (8) Severe dyspepsia, gastrointestinal obstruction, gastric and duodenal ulcers and other gastrointestinal diseases that can affect drug absorption; (9) Combined history of alcohol or psychotropic substance abuse; (10) A history of taking cholinesterase inhibitors, memantine, nimodipine, and Chinese herbal wisdom promoting drugs within the past 1 month; (11) Are participating in other drug clinical trials or have participated in other drug clinical trials for less than 1 month; (12) The investigator considers that there are other circumstances that are not appropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VADAS-cog;CDR-SB; | — |
Secondary
| Measure | Time frame |
|---|---|
| MMSE;TMT-A;BNT-2;HVLT/48;CDT;PSQI;TCM syndrome scale; | — |
Countries
China
Contacts
Public ContactLin Yaming
Yunnan Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed